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Fed Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg

NCT01183676 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-08-18

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

DEPAKOTE® Tablets, 500 MG

1 x 500 mg Tablet, under fed conditions

DRUG

DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG

1 x 500 mg Tablet, under fed conditions

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183676 on ClinicalTrials.gov